Thursday, July 28, 2016

FDA Re-Labels Transvaginal Mesh a High-Risk Medical Device

The U.S. Food and Drug Administration has reclassified transvaginal mesh as a high-risk medical device and ordered manufacturers to address safety concerns by submitting new applications that demonstrate their products are safe and effective. These new requirements apply only to mesh products used to repair pelvic organ prolapse (POP) in women, according to the FDA announcement. Surgery for POP, which occurs when pelvic muscles become weakened, stretched or torn and can no longer support pelvic organs, is often performed using a minimally invasive transvaginal technique where mesh inserts are implanted to reinforce the pelvic muscles. Over the past decade, the FDA has received thousands of complaints about complications from the mesh inserts, including pelvic pain, bleeding, organ damage, infection and urinary problems. The FDA Orders To address these concerns, the FDA has reclassified transvaginal mesh for POP repair from class II (moderate-risk) to class III (high-risk) medical devices. In addition, the FDA has ordered manufacturers to submit a premarket approval (PMA) application to support claims of safety and effectiveness of mesh for POP repair. Manufacturers with products already on the market for POP repair have 30 months to submit a PMA. Manufacturers of new devices must submit a PMA before the FDA will approve a POP repair mesh product for marketing. Prior FDA Warnings The FDA provided fast-track approval for transvaginal mesh products because they were believed to be similar to mesh products long used in hernia surgeries. The agency later issued warnings in 2008 and 2011 to doctors and […]